Sharps prevention devices – simulated use testing
All new prefilled syringes are being developed with integrated sharps prevention features, typically a retracting needle that engages once the user has fully depressed the plunger.
FDA guidance on sharps prevention features from 2005 asks manufacturers to conduct simulated use testing to show that the intended users can use the feature. The guidance recommends testing 500 syringes by asking a sample of users to simulate a total of 500 injections (yes, 500!). What’s more, there should be zero failures of the prevention feature. So that is a failure rate of 0%.
This is a big ask. We know that many patients find it difficult to know exactly when to pull the needle away from the injection site. And this would obviously mean that the prevention feature does not engage as it should. However, a careful reading of the guidance reveals that the focus is on device failure not use error. So provided the study methodology is tightly controlled (something we specialise in) the test becomes a lot more manageable.